Wednesday, December 9, 2015
Zafgen, a Boston-based biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has received verbal notice from the FDA that its beloranib investigational new drug (IND) application has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal phase III ZAF-311 bestPWS clinical trial in patients with Prader-Willi syndrome (PWS). A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the company’s IND application.
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The FDA has approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
Adaptimmune Therapeutics, a clinical stage biopharmaceutical company based in Oxfordshire, U.K. and Philadelphia, has initiated a study of its affinity enhanced T-cell therapy targeting the NY-ESO-1 cancer antigen in patients with stage IIIb or stage IV non-small cell lung cancer (NSCLC), the most common type of lung cancer, representing 85% of lung cancers.
Merck, of Darmstadt, Germany, and Pfizer have announced that the FDA has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.
Pfizer has announced that PROFILE 1029, a phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet.